There is an increased risk of endometrial cancer in a woman with a uterus
who uses unopposed estrogens. Adding a progestin to estrogen therapy has been
shown to reduce the risk of endometrial hyperplasia, which may be a precursor
to endometrial cancer. Adequate diagnostic measures, including directed or random
endometrial sampling when indicated, should be undertaken to rule out malignancy
in postmenopausal women with undiagnosed persistent or recurring abnormal genital
bleeding [see WARNINGS AND PRECAUTIONS].

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular
disease or dementia [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

The WHI Memory Study (WHIMS) estrogen alone ancillary study of WHI reported
an increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 5.2 years of treatment with daily CE (0.625 mg)
alone, relative to placebo. It is unknown whether this finding applies to younger
postmenopausal women [see WARNINGS AND PRECAUTIONS, Use in Specific Populations,
and Clinical Studies].

In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and other dosage forms of estrogens.

Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of
cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS, and Clinical
Studies].

The WHIMS estrogen plus progestin ancillary study of the WHI, reported an
increased risk of developing probable dementia in postmenopausal women 65 years
of age or older during 4 years of treatment with daily CE (0.625 mg) combined
with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies
to younger postmenopausal women [see WARNINGS AND PRECAUTIONS, Use in Specific
Populations, and Clinical Studies].

What are the precautions when taking conjugated estrogens vaginal cream (Premarin Vaginal Cream)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.